The objective of the proposed SBIR Phase-II Competing Renewal under RFA-EY-09-001 is to develop inexpensive and compact ophthalmic instruments for rapid diabetic retinopathy (DR) detection and screening. To achieve the program objective, the key aims will be to [1] generate functional swept-source optical coherence tomography (F-SS-OCT) system at 1060nm spectral region to perform early detection of DR by imaging retinal layers and choroidal microvasculature at video rates, [2] to develop effective image analysis methods to speed screening, and [3] to conduct human clinical trials with the goal to extract the defining DR disease signature. The final F-SS-OCT engine will be a compact, turn-key device that can greatly facilitate integration into a system integrator's ophthalmic imaging instrument for use by primary-care physicians as well as medical professionals at easily accessible public locales and retail stores. The ultimate benefit of this work is to create an affordable and enabling technology to provide both morphological and blood flow information for the diagnosis and management of diabetic retinopathy. Supported by the combined advantages of deep light penetration, minimal tissue dispersion, higher safe light exposure, high sensitivity, resolution, and speed, the 1060nm F-SS-OCT technology should enable superior imaging for DR. Current retinal OCT systems use light sources centered at 820nm for clear intraretinal layer imaging but have insufficient penetration depth for imaging the choroidal microvasculature. The choroid plays an important role in many ocular diseases including DR. Imaging and quantifying choroidal blood flow with F-SS-OCT would provide valuable information in both diagnosing and managing these ocular diseases at earlier stages. Based on the research accomplished in the current Phase-II NEI-SBIR, this renewal program is well positioned to greatly facilitate the commercialization of functional OCT imaging system by extending beyond the current swept laser technology to encompass a fully self-contained F-SS-OCT engine. Therefore, this program will focus on advancing the novel swept laser technology, developing the OCT engine, performing functional OCT imaging tests, conducting human clinical trials, and developing and verifying image analysis methods for rapid DR screening. New product manufacturing process will also be initiated to ensure successful commercialization. PUBLIC HEALTH RELEVANCE: The objective of the program is to develop inexpensive and compact swept source optical coherence tomography engine at 1060nm spectral region for rapid diabetic retinopathy (DR) detection and screening. DR is a significant complication of diabetes and is the third leading cause of blindness in the US.;furthermore, DR remains the leading cause of new blindness in working aged people in the "Western World". Generating real-time measurements of blood flow and correlating the findings with tissue morphology in normal and diseased eyes is a novel and powerful approach to understanding the disease-related abnormalities in the retina. The final engine will be a compact, turn-key device that can greatly facilitate integration into a system integrator's ophthalmic imaging instrument for use by primary-care physicians as well as medical professionals at easily accessible public locales and retail stores. The ultimate benefit of this work is to create an affordable and enabling technology to provide both morphological and blood flow information for the diagnosis and management of diabetic retinopathy.